Market Newsdesk

• Study met primary endpoint showing statistically significant improvement in
  rate of
  prevention of
  G
  rade 4
  neutropenia
  in
  C
  ycle 1,
  p
  =
  0.0015

• Study met statistically significant improvement in key secondary endpoints, including DSN
  Cycle 1 D1-
  8, DSN Cycle 1
  ,
  and
  Mean ANC Nadir Cycle 1

• Plinabulin
  in combination with
  pegfilgrastim
  , a Breakthrough Designation therapy,
  is
  believed to be
  the first
  product candidate
  to show improvement over standard of care
  (
  G-CSF monotherapy
  )
  for
  c
  hemotherapy
  –
  induce
  d
  neutropenia (
  CIN
  )
  , a complication
  which affects
  as many as 440,000 chemotherapy patients
  in the U
  .
  S
  .
  annually
  
• Conference
  c
  all and
  w
  ebcast
  to
  d
  iscuss
  r
  esults
  w
  ill
  b
  e
  h
  eld
  t
  oday at 8:30 a.m. ET

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — BeyondSpring (the “Company” or “BeyondSpring”) (NASDAQ: BYSI), a global biopharmaceutical company focused on the development of innovative cancer therapies, today announced positive topline data from its PROTECTIVE-2 Phase 3 registrational study showing that plinabulin in combination with pegfilgrastim met the primary endpoint with statistically significant improvement in the rate of prevention of Grade 4 neutropenia in Cycle 1 (31.5% vs 13.6%, p=0.0015), as well as achieving statistical significance in all key secondary endpoints, including duration of severe neutropenia (DSN) and absolute neutrophil count (ANC) nadir.

The PROTECTIVE-2 Phase 3 study is a double-blind, active-controlled, global study that enrolled a total of 221 patients. Patients in the trial were treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + pegfilgrastim (6 mg, Day 2 dose) versus a single dose of pegfilgrastim (6 mg, Day 2 dose). The primary efficacy endpoint was rate of prevention of Grade 4 neutropenia.

Plinabulin in combination with pegfilgrastim showed a statistically significant improvement compared to pegfilgrastim alone, with topline data summarized below. Data from all 221 patients were analyzed (combination arm n=111, pegfilgrastim arm n=110).

• Primary endpoint (Rate of prevention of Grade 4 neutropenia): 31.5% combo therapy vs. 13.6% pegfilgrastim monotherapy, 95% CI 17.90 (7.13, 28.66), p = 0.0015
• Key secondary endpoints:
  – DSN Cycle 1 Day 1-8 (ANC < 0.5 x 10⁹ cells/L): p = 0.0065,
  – DSN Cycle 1: p = 0.03
  – Mean ANC nadir Cycle 1 (x 10⁹ cells/L): p = 0.0002
  – Duration of profound neutropenia Cycle 1 (ANC < 0.1 x 10⁹ cells/L): p = 0.0004,
  According to literature, profound neutropenia leads to 80% patient death in first week of infection¹, and 48% febrile neutropenia, or FN, and 50% infection².

• Safety data:
  – Lower Grade 4 adverse event (AE) frequency (58.6%) for combination compared to 80.0% in pegfilgrastim monotherapy  

“These data clearly demonstrate the potential for this combination to offer superior therapy compared to standard of care in the prevention of CIN,” said Douglas W. Blayney, M.D., Professor of Medicine at the Stanford University School of Medicine and the global principal investigator for plinabulin’s CIN studies. “With current therapy, Grade 4 neutropenia still occurs in more than 80% of patients after chemotherapy, primarily in Week 1 after chemotherapy, which increases Emergency Room visits and hospitalizations due to infection and febrile neutropenia. Grade 4 neutropenia is also associated with increased mortality and reduced long-term survival due to reduction, delay, or interruption of chemotherapy. I would like to thank the participating patients, their families and the BeyondSpring team for their dedicated work to advance this combination therapy for the prevention of CIN in chemotherapy patients.”

Ramon Mohanlal, M.D., Ph.D., Chief Medical Officer and Executive Vice President of Research and Development at BeyondSpring noted, “We are pleased to have received Breakthrough Therapy designation from both the U.S. FDA and China NMPA for the plinabulin combination in CIN, underscoring the unmet medical need and potential benefit of the combination. We are working with regulatory agencies on the NDA submission, which is expected in Q1 2021 and have also begun preparation for commercialization. In addition to Plinabulin being developed as a treatment option for the prevention of CIN, it is also being investigated as a direct anticancer agent in a global Phase 3 trial of plinabulin + docetaxel for non-small cell lung cancer (NSCLC), with final data read-out in 1H 2021.”

Conference Call and Webcast Information


BeyondSpring’s management will host a conference call and webcast today at 8:30 a.m. Eastern Time. The dial-in numbers for the conference call are 1-877-451-6152 (U.S.) or 1-201-389-0879 (international). Please reference conference ID: 13713406. A live webcast will be available on BeyondSpring’s website at www.beyondspringpharma.com under “Events & Presentations” in the Investors section. An archived replay of the webcast will be available for 30 days.

¹ Bodey et al. Ann Intern Med 64(2): 328 (1966); ² Bodey et al. Cancer 41(4): 1610 (1978)

About Plinabulin in PROTECTIVE-2 (Study 106) CIN Study 

The Phase 3 portion of PROTECTIVE-2 is a double-blind and active controlled global study. It was designed to evaluate the safety and efficacy in breast cancer, treated with docetaxel, doxorubicin and cyclophosphamide (TAC, Day 1 dose) in a 21-day cycle with plinabulin (40 mg, Day 1 dose) + Pegfilgrastim (6 mg, Day 2 dose) versus a single dose of Pegfilgrastim (6 mg, Day 2 dose). TAC is an example of high febrile neutropenia risk chemotherapy; all G-CSF biosimilar studies use TAC in the pivotal studies.

Plinabulin and G-CSFs such as Pegfilgrastim are believed to have complementary mechanisms in preventing chemotherapy-induced neutropenia (CIN). This is a superiority study in CIN efficacy in the rate of prevention of Grade 4 neutropenia, comparing the combination head-to-head against Pegfilgrastim alone. Literature shows that the Grade 4 neutropenia rate for TAC and Pegfilgrastim at 6 mg is 83 to 93 percent, which presents severe unmet medical needs.

The absolute neutrophil count (ANC) data, which are used to calculate these endpoints, were obtained through central laboratory assessments by Covance Bioanalytical Methods using standardized and validated analytical tests. Covance was the clinical contract research organization (CRO) for patient recruitment and monitoring of global sites for this study.

About
Chemotherapy Induced Neutropenia (
CIN
)

Patients receiving chemotherapy typically develop CIN, a severe side effect that increases the risk of infection with fever (also called febrile neutropenia, or “FN”), which necessitates ER/hospital visits. The updated National Comprehensive Cancer Network (NCCN) guidelines expanded the use of prophylactic G-CSFs, such as Pegfilgrastim, from only high risk patients (chemo FN rate >20%) to intermediate risk patients (FN rate between 10-20%) to avoid hospital/ER visits during the COVID-19 pandemic. The revision of the NCCN guidelines effectively increases the addressable market of patients who may benefit from treatment with plinabulin, if approved, to approximately 440,000 cancer patients in the U.S. annually. Plinabulin is designed to provide protection against the occurrence of CIN and its clinical consequences in week 1, or early onset action after chemotherapy.

About Plinabulin

Plinabulin, BeyondSpring’s lead asset, is an investigational differentiated immune and stem cell modulator. Plinabulin is currently in late-stage clinical development to increase overall survival in cancer patients, as well as to alleviate CIN. Plinabulin had received Breakthrough Therapy Designation from China NMPA in CIN. The U.S. FDA granted Breakthrough Therapy designation to plinabulin for concurrent administration with myelosuppressive chemotherapeutic regimens in patients with non-myeloid malignancies for the prevention of chemotherapy-induced neutropenia (CIN). The durable anticancer benefits of plinabulin observed to date have been associated with its effect as a potent antigen-presenting cell (APC) inducer (through dendritic cell maturation) and T-cell activation (Chem and Cell Reports, 2019). Plinabulin’s CIN data highlight the ability to boost the number of hematopoietic stem / progenitor cells (HSPCs), or lineage-/cKit+/Sca1+ (LSK) cells in mice. Effects on HSPCs could explain the potential ability of plinabulin to not only treat CIN with a rapid onset, but also to reduce chemotherapy-induced thrombocytopenia and increase circulating CD34+ cells in patients.

Plinabulin currently is in an Expanded Access Program in the U.S.

About BeyondSpring

BeyondSpring is a global, clinical-stage biopharmaceutical company focused on the development of innovative cancer therapies. BeyondSpring’s lead asset, plinabulin, a first-in-class agent as an immune and stem cell modulator, is in a Phase 3 global clinical trial as a direct anticancer agent in the treatment of non-small cell lung cancer (NSCLC) and Phase 3 clinical programs in the prevention of CIN. BeyondSpring has strong R&D capabilities with a robust pipeline in addition to plinabulin, including three immuno-oncology assets and a drug discovery platform using the protein degradation pathway, which is being developed in a subsidiary company, Seed Therapeutics, Inc. The Company also has a seasoned management team with many years of experience bringing drugs to the global market. BeyondSpring is headquartered in New York City.

Cautionary Note Regarding Forward-Looking Statements

This press release includes forward-looking statements that are not historical facts. Words such as “will,” “expect,” “anticipate,” “plan,” “believe,” “design,” “may,” “future,” “estimate,” “predict,” “objective,” “goal,” or variations thereof and variations of such words and similar expressions are intended to identify such forward-looking statements. Forward-looking statements are based on BeyondSpring’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, difficulties raising the anticipated amount needed to finance the Company’s future operations on terms acceptable to the Company, if at all, unexpected results of clinical trials, delays or denial in regulatory approval process, results that do not meet our expectations regarding the potential safety, the ultimate efficacy or clinical utility of our product candidates, increased competition in the market, and other risks described in BeyondSpring’s most recent Form 20-F on file with the U.S. Securities and Exchange Commission. All forward-looking statements made herein speak only as of the date of this release and BeyondSpring undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Investor Contact:

Ashley R. Robinson
LifeSci Advisors, LLC
+1 617-430-7577
[email protected] 

Media Contact:

Darren Opland, Ph.D.
LifeSci Communications
+1 646-627-8387
[email protected] 

BLUE BELL, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) — Rego Payment Architectures, Inc. (“REGO”) (OTCQB:RPMT) today announced that it will be entering the Beta Phase of its COPPA (“Child Online Privacy Protection Act”) and GDPR (“General Data Protection Regulation”) compliant Digital Wallet App – “Mazoola^TM” and onboarding users. The Alpha Phase, that the Company has completed, provided valuable information regarding the use of the app from the parent and child viewpoints. This knowledge has now been integrated into the app and REGO is ready to progress to the Beta Phase launch.

Through the Beta test, we will be evaluating the app in a realistic environment. This will focus efforts on previously unidentified design issues. This will enable Rego to commercially launch a product that meets the standards of quality, usability and performance of our customers. Once the Beta Phase is completed, REGO anticipates commercially launching its Mazoola^TM App, on December 15, 2020.

REGO’s Mazoola^TM app is an unprecedented family-focused financial and COPPA and GDPR compliant solution. It allows children to shop from parent-approved retailers, deliver peer-to-peer payments, teaches financial literacy, all while keeping identities secure and safe. REGO has patented attribution and identity management methods, patented real-time access and data control, and independent verification, validation, and auditing techniques, among other core capabilities.

Peter S. Pelullo, Chief Executive Officer, REGO said: “Our team and our highly successful group of industry subcontractors have worked together and kept to our timetable initiated three months ago. Delivery of the first all digital COPPA and GDPR compliant payment platform that protects and teaches children financial responsibility has been challenging, but also has been a more than worthwhile endeavor to insure the safety of the 70 million plus 17 and under consumers.”

Safe


Harbor Statement


The information in this press release may contain forward-looking statements on our current expectations and projections about future events. These forward-looking statements are not guarantees and are subject to known and unknown risks, uncertainties, and assumptions about us that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Important factors that could cause actual results to differ materially from our expectations include, but are not limited to: our ability to raise additional capital, the absence of any material operating history or revenue, our ability to attract and retain qualified personnel, our ability to develop and introduce a new service and products to the market in a timely manner, market acceptance of our services and products, our limited experience in the industry, the ability to successfully develop licensing programs and generate business, rapid technological change in relevant markets, unexpected network interruptions or security breaches, changes in demand for current and future intellectual property rights, legislative, regulatory and competitive developments, intense competition with larger companies, general economic conditions, and other risks as described by us in Item 1.A “Risk Factors” in our most recent Form 10-K; other risks to which our Company is subject; other factors beyond the Company’s control.

All subsequent written and oral forward-looking statements attributable to us, or persons acting on our behalf, are expressly qualified in their entirety by the foregoing. The Company has no obligation to and does not undertake to update, revise, or correct any of these forward-looking statements after the date of this report.

About REGO Payment Architectures, Inc.


REGO is a digital solution that enables children to stay safe in today’s tech-first environment. The REGO Digital Wallet platform allows parents and guardians to enable online shopping or digital spending at approved retailers, control what funds are available for which purchases, and reward children or pay allowance via the app. REGO is an innovative financial platform uniquely positioned due to its Children’s Online Privacy Protection Act (COPPA) and General Data Protection Regulation (GDPR) compliance. Visit us at regopayments.com

Media Contact:

Scott A. McPherson

REGO Payment Architectures, Inc.
325 Sentry Parkway, Suite 200
Blue Bell, PA 19422

[email protected]

(o) 267-465-7530

Data released today expands on
November 15, 2020
AASLD presentation

Repeat dosing of 60 mg AB-729 every 4 weeks resulted in
robust and continuous
mean
declines in
HBsAg decline at week 20 (-1.71 log10IU/mL
, N=7
)
and
f
urther reductions continued beyond week 20 (-1.84 log10 IU/mL, N=3)

In HBV DNA positive subjects, a single 90 mg AB-729 dose resulted in robust
mean
declines in
HBsAg (
-1.02 log10 IU/mL
)
,
HBV DNA (
-1.5
3
log10 IU/mL
)
, HBV RNA and
HBcrAg
at week 12

Results
support advanc
ement in
to Phase 2 combination
clinical trials
with AB-729 dosing
as infrequently as
every 8 or 12 weeks

Conference Call and Webcast Scheduled
Today at 8:00 am ET

WARMINSTER, Pa., Nov. 16, 2020 (GLOBE NEWSWIRE) —  Arbutus Biopharma Corporation (Nasdaq: ABUS), a clinical-stage biopharmaceutical company primarily focused on developing a cure for people with chronic hepatitis B virus (HBV) infection as well as therapies to treat coronaviruses (including COVID-19), today announced additional clinical data from an ongoing Phase 1a/1b clinical trial (AB-729-001) with AB-729, its proprietary GalNAc delivered RNAi compound.

The new data described today expands on the presentation entitled Safety and pharmacodynamics of the GalNAc-siRNA AB-729 in subjects with chronic hepatitis B infection, recorded on October 14, 2020 and presented on November 15, 2020 by Professor Man-Fung Yuen, D.Sc., M.D., Ph.D., from the University of Hong Kong at The Liver Meeting Digital Experience^TM, The American Association for the Study of Liver Diseases (AASLD) Meeting.

The new data summarized below include HBsAg data for the complete 60 mg every 4 weeks multi-dose cohort (N=7) at week 20, and the first results for the AB-729 90 mg single-dose cohort of HBV DNA positive subjects (N=5).

William Collier, President and Chief Executive Officer of Arbutus, stated, “The positive data described today, together with the strong safety and efficacy results presented by Professor Yuen at AASLD yesterday, are encouraging and continue to support our confidence in the therapeutic value of AB-729 as we plan to move into Phase 2 clinical trials.”

Summary of new data

Repeat dosing of AB-729 60 mg every 4 weeks results in continuous
declines in
mean
HBsAg through week 20
(Cohort E)

Dr. Gaston Picchio, Chief Development Officer at Arbutus stated, “Further follow up of the 60 mg every 4 weeks multi-dose cohort confirmed continuous reductions in mean HBsAg at week 20 (N=7), and in a subset of subjects (N=3) beyond this time point, while being generally safe and well tolerated. Additionally, the mean HBsAg declines and slopes of declines are similar between single doses and repeat doses of AB-729 up to week 12. Importantly, this suggests that dosing AB-729 as frequently as every 4 weeks may not be necessary, and that AB-729 has the potential to be dosed every 8 weeks or even every 12 weeks. This dosing strategy is being investigated in other cohorts of the trial with results from the 60 mg every 8 week cohort expected before the end of 2020.”

AB-729 90 mg single-dose reduces HBsAg and HBV DNA in HBV DNA positive chronic Hepatitis B (CHB)subjects with mean HBsAg declinessimilar to those seen in HBV DNA negativesubjects (Cohort D)

Dr. Picchio added, “It is also encouraging to observe that a single 90 mg dose of AB-729 is capable of reducing HBsAg in HBV DNA positive subjects to the same extent achieved in other single-dose HBV DNA negative cohorts. Further, a single 90 mg AB-729 dose substantially reduced HBV DNA as well as HBV RNA and HBcrAg.”

AB-729 was safe and well tolerated after single and rep
eat doses

• No serious adverse events or discontinuations due to adverse events
• No treatment-related Grade 3 or 4 adverse events

Summary of clinical trial design 

AB-729-001 is an ongoing first-in-human clinical trial consisting of three parts:

In Part 1, three cohorts of healthy subjects were randomized 4:2 to receive single-doses (60 mg, 180 mg or 360 mg) of AB-729 or placebo.

In Part 2, non-cirrhotic, HBeAg positive or negative, chronic HBV subjects (N=6) on a background of nucleos(t)ide therapy with HBV DNA below the limit of quantitation received single-doses (60 mg to 180 mg) of AB-729. An additional cohort in Part 2 included 90 mg single-dose of AB-729 in HBV DNA positive chronic HBV subjects.

In Part 3, chronic HBV subjects, HBV DNA negative first and HBV DNA positive later, are receiving multi-doses of AB-729 for up to six months.

About AB-729 

AB-729 is an RNA interference (RNAi) therapeutic targeted to hepatocytes using Arbutus’ novel covalently conjugated N-acetylgalactosamine (GalNAc) delivery technology that enables subcutaneous delivery. AB-729 inhibits viral replication and reduces all HBV antigens, including hepatitis B surface antigen in preclinical models. Reducing hepatitis B surface antigen is thought to be a key prerequisite to enable reawakening of a patient’s immune system to respond to the virus. In an ongoing single- and multi-dose Phase 1a/1b clinical trial, AB-729 demonstrated positive safety and tolerability data and meaningful reductions in hepatitis B surface antigen.

About HBV

Chronic hepatitis B virus (HBV) infection is a debilitating disease of the liver that afflicts over 250 million people worldwide with up to 90 million people in China, as estimated by the World Health Organization. HBV is a global epidemic that affects more people than hepatitis C virus (HCV) and HIV infection combined—with a higher morbidity and mortality rate. HBV is a leading cause of chronic liver disease and need for liver transplantation, and up to one million people worldwide die every year from HBV-related causes.

The current standard of care for patients with chronic HBV infection is life-long suppressive treatment with medications that reduce, but do not eliminate, the virus, resulting in very low cure rates. There is a significant unmet need for new therapies to treat HBV.

Conference Call and Webcast Today

Arbutus will hold a conference call and webcast today, Monday, November 16, 2020 at 8:00 am Eastern Time to provide an AB-729 clinical update. You can access a live webcast of the call, which will include presentation slides, through the Investors section of Arbutus’ website at www.arbutusbio.com or directly at Live Webcast. Alternatively, you can dial (866) 393-1607 or (914) 495-8556 and reference conference ID 7791835.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling (855) 859-2056 or (404) 537-3406, and reference conference ID 7791835.

About Arbutus

Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company primarily dedicated to discovering, developing and commercializing a cure for people with chronic hepatitis B virus (HBV) infection. The Company is advancing multiple drug product candidates that may be combined into a potentially curative regimen for chronic HBV infection. Arbutus has also initiated a drug discovery and development effort for treating coronaviruses (including COVID-19). For more information, please visit www.arbutusbio.com.

Forward-Looking Statements and Information

This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about the Company’s expectations to conduct Phase 2 combination studies with AB-729 dosing as infrequently as every 8 or 12 weeks; the Company’s expectation that AB-729 could be effective at dosing intervals of every 8 or even every 12 weeks; the Company’s expectations that additional data results from the AB-729 60 mg 8 week cohort will be available before the end of 2020; and the Company’s expectation that AB-729 could be the cornerstone of future combination regimens for the treatment of chronic hepatitis B infection.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of preclinical studies and clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies, including uncertainties and contingencies related to the ongoing COVID-19 pandemic.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated pre-clinical studies and clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may elect to change its strategy regarding its product candidates and clinical development activities; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; market shifts may require a change in strategic focus; and the ongoing COVID-19 pandemic could significantly disrupt Arbutus’ clinical development programs.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’ continuous and periodic disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information

Investors and Media

William H. Collier
President and CEO
Phone: 267-469-0914
Email: [email protected]

Pam Murphy
Investor Relations Consultant
Phone: 267-469-0914
Email: [email protected]

CAMBRIDGE, Ma., Nov. 16, 2020 (GLOBE NEWSWIRE) — Trillium Therapeutics Inc. (“Trillium” or the “Company”) (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, today reported financial and operating results for the nine months ended September 30, 2020.

“Third quarter was a productive quarter for Trillium,” said Jan Skvarka, the Company’s President and Chief Executive Officer. “We reported encouraging clinical data updates for both TTI-622 and TTI-621, announced a $25 million equity investment from Pfizer, raised $150 million in a follow-on offering, and added Dr. Michael Kamarck to the Board of Directors. After the close of the third quarter, we announced formation of a Scientific Advisory Board, appointment of Dr. Ingmar Bruns as our new Chief Medical Officer, and addition of Mr. Paolo Pucci to the Board of Directors. With close to $300 million in cash, we are well capitalized to embark on a Phase 2 program in heme and solid tumor malignancies in 2021.”

TTI-622 Study Update provided in the third quarter of 2020:

• In the Phase 1a/1b study in patients with advanced relapsed or refractory lymphoma or multiple myeloma (NCT03530683), the Company reported that a total of six objective responses (33%; 1 complete response, 5 partial responses) have been observed among 18 response evaluable patients treated at dose levels of 0.8, 2.0, 4.0 and 8.0 mg/kg. Responses had occurred across all dose levels in this range, with three of six (50%) patients achieving responses in the 8.0 mg/kg cohort (response assessment for one additional patient at 8 mg/kg dose not available as of the cutoff date).
• The safety assessment of the 8 mg/kg dosing cohort was successfully completed with one Grade 4 thrombocytopenia dose-limiting toxicity (DLT) reported among the six evaluable patients and no additional Grade 3 or higher thrombocytopenia events observed.
• Clinical responses had been observed across multiple lymphoma indications, including diffuse large B-cell lymphoma, cutaneous T-cell lymphoma with large cell transformation, peripheral T-cell lymphoma, and follicular lymphoma.
• All responses were observed at the first assessment at 8 weeks.
• The study began enrolling patients at the 12 mg/kg dose level.

TTI-621 Study Update provided in the third quarter of 2020:

• In the Phase 1 study in patients with advanced relapsed or refractory hematologic malignancies (NCT02663518), preliminary data from Part 4 indicated the weekly infusions of TTI-621 up to 1.4 mg/kg were well tolerated without dose-limiting thrombocytopenia. Platelet decreases generally occurred on dosing days, recovered in 2-4 days, and had not worsened with increasing dose levels. Infusion-related reactions (IRRs) typically occurred during initial infusions and often resolved without recurrence. One Grade 3 IRR DLT was observed at 1.0 mg/kg.
• Antitumor activity in the 1 mg/kg cohort included 1 partial response and 1 skin complete response (overall assessment stable disease) in 6 evaluable patients; 2 patients were bridged to allogeneic transplantation. Preliminary data suggested dose-dependent improvements in modified severity weighted assessment tool (mSWAT) scores in the 0.5 to1.0 mg/kg cohorts (1.4 mg/kg cohort data not yet available).
• The study began enrolling patients at the 2.0 mg/kg dose level.

Financings:

In September 2020, the Company issued 2,297,794 common shares at a price of $10.88 per share to Pfizer Inc. in a registered direct offering. The gross proceeds from this offering were $25.0 million, before deducting offering expenses of $0.1 million.

In September 2020, the Company also completed an underwritten public offering of 11,500,000 common shares, at a public offering price of $13.00 per share. The number of shares sold include 1,500,000 common shares pursuant to the full exercise by the underwriters of their option to purchase additional common shares. The gross proceeds from this offering were $149.5 million, before deducting underwriting discounts and commissions, and offering expenses of $9.1 million.

Governance changes:

In September 2020, Dr. Michael Kamarck joined the Board of Directors. Dr. Kamarck is Chief Technology Officer for Vir Biotechnology, Inc. and has significant experience and expertise with the development and manufacturing of biologic products.

In addition, Paolo Pucci joined the Board of Directors on November 12, 2020 and brings significant expertise in oncology drug development and commercialization. He most recently served as CEO of ArQule until it was acquired by Merck for $2.7 billion in January 2020.

Third Quarter 2020 Financial Results:

As of September 30, 2020, Trillium had cash and cash equivalents and marketable securities of $292.4 million, compared to $22.7 million at December 31, 2019. The increase in cash and cash equivalents and marketable securities was due mainly to proceeds from financings completed in January 2020 and September 2020.

Net loss for the nine months ended September 30, 2020 of $173.0 million was higher than the loss of $22.4 million for the nine months ended September 30, 2019. The net loss was higher due mainly to a net warrant liability revaluation loss of $132.7 million, a loss of $22.1 million on the revaluation of the deferred share unit (DSU) liability (reclassified from a liability to equity effective June 30, 2020 on adoption of the new omnibus incentive plan), and higher manufacturing costs. This was partially offset by lower clinical trial expenses, salary expenses, intangible assets amortization, and share-based compensation. Trillium’s outstanding warrants are a non-cash liability, and revaluation losses on the Company’s warrant liability balance are of a non-cash nature.

Selected Consolidated Financial Information:

About Trillium Therapeutics

Trillium is an immuno-oncology company developing innovative therapies for the treatment of cancer. The company’s two clinical programs, TTI-621 and TTI-622, target CD47, a “don’t eat me” signal that cancer cells frequently use to evade the immune system.

For more information visit: www.trilliumtherapeutics.com 

Caution Regarding Forward-Looking Information

This press release contains forward-looking statements within the meaning of applicable United States securities laws and forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about, without limitation, our expectation of initiating a Phase 2 program in heme and solid tumor malignancies in 2021 and enrollment in our TTI-622 and TTI-621 studies. With respect to the forward-looking statements contained in this press release, Trillium has made numerous assumptions regarding, among other things: the impact of the Covid-19 pandemic on its operations, the effectiveness and timeliness of preclinical and clinical trials; and the completeness, accuracy and usefulness of the data. While Trillium considers these assumptions to be reasonable, these assumptions are inherently subject to significant scientific, business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors that could cause Trillium’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained in this press release. A discussion of risks and uncertainties facing Trillium appears in Trillium’s Annual Information Form for the year ended December 31, 2019 filed with Canadian securities authorities and on Form 40-F with the U.S. Securities Exchange Commission, each as updated by Trillium’s continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Trillium disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Investor Relations:

James Parsons
Chief Financial Officer
Trillium Therapeutics Inc.
416-595-0627 x232
[email protected]
www.trilliumtherapeutics.com

Media Relations:

Mike Beyer
Sam Brown Inc.
312-961-2502
[email protected]

– Continued progress in OVAL Phase 3 potential-registration study in patients with platinum-resistant ovarian cancer; high response rates (RR) of over 50% in the total evaluable patient population with approximately 200 patients enrolled to date

– Management to host conference call and webcast at 8:30 am Eastern Time Today

TEL AVIV, Israel, Nov. 16, 2020 (GLOBE NEWSWIRE) — VBL Therapeutics (Nasdaq: VBLT), today reported its financial results for the third quarter ended September 30, 2020, and provided a corporate update.

“The clinical development program for VB-111, our unique gene therapy for solid tumors, continues to advance well. Patient enrollment in the OVAL Phase 3 study in ovarian cancer continues to be ahead of plan, with almost 200 patients enrolled to date. We had two positive DSMC analyses, indicating that our OVAL trial remains on the right track,” said Dror Harats, M.D., Chief Executive Officer of VBL Therapeutics. “While it is important to note that the study remains blinded, we are encouraged by the very high response rate (RR), over 50%, that we continue to see to date. This RR is impressively higher than expected for standard-of-care treatments, for which RR is typically in the teens. If successful, the OVAL trial has the potential to establish VB-111 as a new standard of care in a challenging disease setting where patients currently have limited options.”

Third Quarter and Recent Key Corporate Highlights:

VB-111

MOSPD2

Corporate:

Third Quarter 2020 Financial Results

Cash Position. As of September 30, 2020, VBL had cash, cash equivalents, short-term bank deposits and restricted bank deposit totaling $37.3 million and working capital of $30.8 million. VBL expects that its cash and cash equivalents and short-term bank deposits will be sufficient to fund operating expenses and capital expenditure requirements into the third quarter of 2022.

Revenue: Revenues for the third quarter, 2020 were $193 thousand, compared to $79 thousand for the comparable period in 2019.

Research and Development (R&D) Expenses: R&D expenses were $4.8 million for the three months ended September 30, 2020, compared to $3.8 million for the three months ended September 30, 2019.

General and Administrative (G&A) Expenses: G&A expenses were $1.1 million for the three months ended September 30, 2020, compared to $1.2 million for the three months ended September 30, 2019.

Comprehensive Loss: VBL reported a net loss of $5.8 million for the three months ended September 30, 2020, compared to a net loss of $4.9 million for the three months ended September 30, 2019.

For further details on VBL’s financials, please refer to Form 6-k filed with the SEC.

Conference Call:

Monday, November 16 @ 8:30 a.m. ET.

As previously announced, VBL will host a webcast Monday, November 16, 2020, at 8:30 a.m. ET.

The live webcast will be available online and may be accessed from the “Events and Presentation” page of the company website. A replay of the webcast will be available beginning approximately one hour after the conclusion of the call and will remain available for at least 30 days thereafter.

About VBL

Vascular Biogenics Ltd., operating as VBL Therapeutics, is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class treatments for areas of unmet need in cancer and immune/inflammatory indications. VBL has developed three platform technologies: a gene-therapy based technology for targeting newly formed blood vessels with focus on cancer, an antibody-based technology targeting MOSPD2 for anti-inflammatory and immuno-oncology applications, and the Lecinoxoids, a family of small-molecules for immune-related indications. VBL’s lead oncology product candidate, ofranergene obadenovec (VB-111), is a first-in-class, targeted anti-cancer gene-therapy agent that is being developed to treat a wide range of solid tumors. It is conveniently administered as an IV infusion once every 6-8 weeks. It has been observed to be well-tolerated in >300 cancer patients and demonstrated activity signals in a VBL-sponsored “all comers” Phase 1 trial as well as in three VBL-sponsored tumor-specific Phase 2 studies. Ofranergene obadenovec is currently being studied in a VBL-sponsored Phase 3 potential registration trial for platinum-resistant ovarian cancer.

Forward Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. These forward-looking statements include, but are not limited to, statements regarding our programs, including VB-111, including their clinical development, such as the timing of clinical trials and expected announcement of data, therapeutic potential and clinical results, and our financial position and cash runway. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, the risk that historical clinical trial results may not be predictive of future trial results, the impact of the COVID-19 pandemic on our business, operations, clinical trials, supply chain, strategy, goals and anticipated timelines and clinical results, that our financial resources do not last for as long as anticipated, and that we may not realize the expected benefits of our intellectual property protection. A further list and description of these risks, uncertainties and other risks can be found in our regulatory filings with the U.S. Securities and Exchange Commission, including in our annual report on Form 20-F for the year ended December 31, 2019, and subsequent filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. VBL Therapeutics undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

INVESTOR CONTACT:

Irina Koffler
LifeSci Advisors
[email protected]
(646) 970-4681

VASCULAR BIOGENICS LTD.

CONDENSED INTERIM STATEMENTS OF FINANCIAL POSITION

(UNAUDITED)

VASCULAR BIOGENICS LTD.

CONDENSED INTERIM STATEMENTS OF NET LOSS AND COMPREHENSIVE LOSS

(UNAUDITED)

iValue is India’s premium technology aggregator with direct partnerships with more than 30 “Best of Breed” OEMs, over 6,000 customers through 600+ partners worldwide

HERZLIYA, Israel, Nov. 16, 2020 (GLOBE NEWSWIRE) — Safe-T® Group Ltd. (Nasdaq, TASE: SFET), a provider of secure access solutions for on-premise and hybrid cloud environments, and iValue InfoSolutions Pvt. Ltd. (“iValue”), India’s premium technology aggregator, today announced the teaming up of Safe-T Group’s wholly-owned subsidiary, Safe-T Data A.R Ltd. (“Safe-T”) and iValue. Security is of optimal importance now more than ever, and iValue, which has consistently stayed ahead by partnering with the right mix of popular and niche technology providers, has once again come to the aid of organizations by bringing forth Safe-T’s Zero Trust Network Access (“ZTNA”) solutions. iValue’s customers across India benefit from this security solution that mitigates attacks on enterprises’ business-critical services and sensitive data, while ensuring uninterrupted business continuity.

IT leadership in enterprises around the world have been working relentlessly for the past several months to design, build and operate effective and secure infrastructure for employees, suppliers and purchasers working remotely. This mass scale change in access methodology has brought about a compelling transition from a ‘trust but verify’ to a ‘trust nothing, always verify’ approach. This new approach is based on the ‘Zero Trust Model,’ which ensures secure access based on three key concepts:

1. Trust nothing
2. Continuous authentication
3. Least privilege access

“Safe-T has mastered unique and innovative technology to enable customers to achieve ‘Comprehensive Zero Trust Architecture’ for remote users, along with protecting investments in traditional and vulnerable VPN solutions,” said Harsh Marwah, Chief Growth Officer of iValue.

Safe-T enables digital business on-premises and in the cloud by allowing access to applications, services and networks only after assessing trust. Safe-T’s cloud and on-premises solutions ensure that organization’s access use cases, whether into the organization or from the organization out to the internet, are secured according to the ‘validate first, access later’ philosophy of Zero Trust. Safe-T’s wide range of access solutions reduce organizations’ attack surface and improve their ability to defend against modern cyber threats.

Using Safe-T’s ZoneZero™ Perimeter Access, ZoneZero™ SDP, ZoneZero™ VPN, ZoneZero™ MFA, Secure File Access (SFA) and Secure Data Access (SDA), organizations can now provide to company resources complete zero trust access for remote employees, partners, applications, IoT devices and more, regardless of their location.

“iValue is a highly-valued partner as we look to expand in India. With over 6,000 customers across industry verticals and more than 15 years of industry experience with a wide range of products and solutions, iValue is an ideal strategic fit for us to introduce our innovative solutions to this market,” said Avi Rubinstein, Safe-T’s Chief Business Officer. “VPNs have stood the test of time, but despite being a cornerstone in secure networking for decades, their infrastructure simply does not support ZTNA. Our ZoneZero™ VPN changes that, allowing organizations to continue to benefit from everything their VPNs have to offer, while implementing zero trust and secure access.”

Digital asset protection is one of iValue’s most sought after solutions. The partnership between iValue and Safe-T with ZTNA solutions will not just make the technology aggregator stronger but will also give a chance for organizations in India to make a worthy investment in safeguarding their DNA.

“With the prevailing pandemic situation, Zero Trust security access to the infrastructure of customers of all sizes has gained utmost relevance. As a variety of brands offer this solution, speedy deployment and ease of integration is the key differentiator for success of any deployment of Zero trust security. Safe-T offers this key ingredient with Zone Zero that is easy to integrate with the existing security, besides offering an end-to-end Zero Trust access to the resources. This feature echoes with iValue’s tagline of ‘Maximizing the value of Technology investments.’ Being an Israeli company, Safe-T assures the product quality and adds value to the security portfolio of iValue,” said Mukundan G S, National Business Manager of iValue InfoSolutions.

About iValue InfoSolutions:

A premium technology enabler, iValue InfoSolutions drives “Go to Market” for niche, compelling and complimentary offerings, “digital assets” protection, optimization and transformation area, leveraging customer life cycle and product life cycle adoption frameworks.

iValue’s mission is to optimize, protect and transform “Digital Assets” of organizations, with leading edge and proven offerings, in collaboration with trusted partners. iValue offerings are aligned, customized and optimized for organizations, across vertical & size, through its OEM, consultant & global, national, regional and local system integrators partnerships.

iValue has a direct partnership with 30+ “Best of Breed” OEMs for its 6,000+ customers through 600+ partners. iValue has a direct presence across 13+ locations in multiple continents, with channel, solution, vertical and horizontal focused teams, addressing pre-sales, sales and post sales needs of customers, consultants and partners for private, public and hybrid cloud needs. Apart from India, iValue’s overseas presence includes Nairobi, Kenya office for Africa.

The team at iValue leverage analytics is known for its structured and targeted business development with customers, along with AI-driven CRM solutions for ensuring profitable growth for its partners and OEMs.

For more information, visit iValue and follow us on LinkedIn and Twitter.

About Safe-T® Group Ltd.

 

Safe-T Group Ltd. (Nasdaq, TASE: SFET) is a provider of Zero Trust Access solutions which mitigate attacks on enterprises’ business-critical services and sensitive data, while ensuring uninterrupted business continuity. Safe-T’s cloud and on-premises solutions ensure that an organization’s access use cases, whether into the organization or from the organization out to the internet, are secured according to the “validate first, access later” philosophy of Zero Trust. This means that no one is trusted by default from inside or outside the network, and verification is required from everyone trying to gain access to resources on the network or in the cloud.

Safe-T’s wide range of access solutions reduce organizations’ attack surface and improve their ability to defend against modern cyberthreats. As an additional layer of security, our integrated business-grade global proxy solution cloud service enables smooth and efficient traffic flow, interruption-free service, unlimited concurrent connections, instant scaling and simple integration with our services.

With Safe-T’s patented reverse-access technology and proprietary routing technology, organizations of all size and type can secure their data, services and networks against internal and external threats.

Safe-T’s SDP solution on AWS Marketplace is available here.

For more information about Safe-T, visit www.safe-t.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, Safe-T is using forward-looking statements in this press release when it discusses the advantages of its ZTNA solution, the potential of the relationship with iValue InfoSolutions, the benefits of partnership between Safe—T and iValue to organizations in India, the potential of the ZTNA solution and/or the resale agreement to address market need and/or demand and the expansion to the market in India. Because such statements deal with future events and are based on Safe-T’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of Safe-T could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading “Risk Factors” in Safe-T’s annual report on Form 20-F filed with the Securities and Exchange Commission (“SEC”) on March 31, 2020, and in any subsequent filings with the SEC. Except as otherwise required by law, Safe-T undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. References and links to websites have been provided as a convenience, and the information contained on such websites is not incorporated by reference into this press release.

SAFE-T CONTACT:
Maya Meiri
M: +972(0)52 3259171
[email protected]